Guidewire Extension System For A Catheter Placement Device

ABSTRACT

An insertion tool for inserting a catheter into a patient&#39;s body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly may be included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/099,050, filed Dec. 6, 2013, now U.S. Pat. No. 9,872,971, whichclaims the benefit of U.S. Provisional Application No. 61/771,703, filedMar. 1, 2013, titled “Needle Safety and Guidewire Extension Systems fora Catheter Insertion Device”, and which is a continuation-in-part ofU.S. patent application Ser. No. 13/107,781, filed May 13, 2011, nowU.S. Pat. No. 8,932,258, which claims the benefit of the following: 1)U.S. Provisional Application No. 61/345,005, filed May 14, 2010, titled“Catheter Insertion System Including an Integrated Guidewire Dilator;”2) U.S. Provisional Application No. 61/345,022, filed May 14, 2010,titled “Systems and Methods for Placement of an Intermediate DwellCatheter Including a Needle Blunting System;” 3) U.S. ProvisionalApplication No. 61/372,050, filed Aug. 9, 2010, titled “CatheterInsertion Tool Including Fold-out Guidewire Advancement Flaps;” and 4)U.S. Provisional Application No. 61/385,844, filed Sep. 23, 2010, titled“Catheter Insertion Tool Including Guidewire Advancement.” Each of theaforementioned applications is incorporated herein by reference in itsentirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toan insertion tool for inserting a catheter or other tubular medicaldevice into a body of a patient. The insertion tool in one embodimentunifies needle insertion, guidewire advancement, and catheter insertionin a single device to provide for a simple catheter placement procedure.

In one embodiment, the insertion tool comprises a housing in which atleast a portion of the catheter is initially disposed, a hollow needledistally extending from the housing with at least a portion of thecatheter pre-disposed over the needle, and a guidewire pre-disposedwithin the needle. An advancement assembly is also included forselectively advancing the guidewire distally past a distal end of theneedle in preparation for distal advancement of the catheter. In oneembodiment a catheter advancement assembly is also included forselectively advancing the catheter into the patient. Each advancementassembly can include a slide or other actuator that enables a user toselectively advance the desired component.

In one embodiment the catheter advancement assembly further includes ahandle that is initially and removably attached to a hub of the catheterwithin the housing. Distal movement of handle by a user in turn distallymoves the catheter distally from the housing. The handle can include aneedle safety component for isolating a distal tip of the needle whenthe needle is removed from the catheter and the distal tip received intothe handle. In addition, various guidewire and catheter advancementassemblies are disclosed herein.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A and 1B are various views of a catheter insertion deviceaccording to one embodiment;

FIGS. 2A and 2B are various exploded views of the catheter insertiondevice of FIGS. 1A and 1B;

FIGS. 3A and 3B show various views of one stage of use of the catheterinsertion tool of FIGS. 1A and 1B according to one embodiment;

FIGS. 4A and 4B show various views of one stage of use of the catheterinsertion tool of FIGS. 1A and 1B according to one embodiment;

FIGS. 5A and 5B show various views of one stage of use of the catheterinsertion tool of FIGS. 1A and 1B according to one embodiment;

FIGS. 6A and 6B show various views of one stage of use of the catheterinsertion tool of FIGS. 1A and 1B according to one embodiment;

FIGS. 7A and 7B show various views of one stage of use of the catheterinsertion tool of FIGS. 1A and 1B according to one embodiment;

FIG. 8 shows one stage of use of the catheter insertion tool of FIGS. 1Aand 1B according to one embodiment;

FIG. 9 shows one stage of use of the catheter insertion tool of FIGS. 1Aand 1B according to one embodiment;

FIGS. 10A-10C shows various views of a needle safety component andenvironment for a catheter insertion tool, according to one embodiment;

FIGS. 11A-11D are various views of a catheter insertion device accordingto one embodiment;

FIGS. 12A and 12B are various views of a portion of the catheterinsertion device of FIGS. 11A-11D;

FIGS. 13A and 13B are various views of a portion of the catheterinsertion device of FIGS. 11A-11D;

FIGS. 14A-14F show various stages of use of the catheter insertion toolof FIGS. 11A-11D according to one embodiment;

FIGS. 15A and 15B are various views of a catheter insertion deviceaccording to one embodiment;

FIG. 16 is a cross sectional side view of an integratedguidewire/dilator for use with the catheter insertion device of FIGS.15A and 15B;

FIGS. 17A-17C are various views of a slotted needle for use with thecatheter insertion device of FIGS. 15A and 15B according to oneembodiment;

FIG. 18 is a cross sectional side view of a portion of the catheterinsertion device of FIGS. 15A and 15B;

FIG. 19 shows one stage of use of the catheter insertion tool of FIGS.15A and 15B according to one embodiment;

FIGS. 20A and 20B show one stage of use of the catheter insertion toolof FIGS. 15A and 15B according to one embodiment;

FIGS. 21A and 21B show one stage of use of the catheter insertion toolof FIGS. 15A and 15B according to one embodiment;

FIG. 22 shows one stage of use of the catheter insertion tool of FIGS.15A and 15B according to one embodiment;

FIG. 23 shows one stage of use of the catheter insertion tool of FIGS.15A and 15B according to one embodiment;

FIG. 24 shows one stage of use of the catheter insertion tool of FIGS.15A and 15B according to one embodiment;

FIGS. 25A and 25B shows various views of a needle distal tip andguidewire blunting design according to one embodiment;

FIG. 26 is a perspective view of a needle distal tip design according toone embodiment;

FIG. 27 is a perspective view of a catheter insertion tool according toone embodiment;

FIG. 28 is a cross sectional view of a catheter insertion tool accordingto one embodiment;

FIGS. 29A and 29B are various views of a catheter insertion toolaccording to one embodiment;

FIG. 30 is a perspective view of a catheter insertion tool according toone embodiment;

FIG. 31 is a perspective view of a catheter insertion tool according toone embodiment;

FIGS. 32A-32I are various views of a configuration of a catheterinsertion tool during use, according to one embodiment;

FIGS. 33A-33C are various views of a safety needle component accordingto one embodiment;

FIG. 34 is an exploded view of a catheter insertion device according toone embodiment;

FIG. 35 is a perspective view of a portion of a guidewire leveraccording to one embodiment;

FIGS. 36A and 36B are cutaway views of a proximal portion of thecatheter insertion device of FIG. 34;

FIG. 37 is a perspective view of a proximal portion of the top housingportion of the catheter insertion device of FIG. 34;

FIG. 38 is a cutaway view of a proximal portion of the catheterinsertion device of FIG. 34;

FIGS. 39A and 39B are various views of a needle safety componentaccording to one embodiment;

FIGS. 40A-40D are various views of the needle safety component of FIGS.39A and 39B and an accompanying carriage; and

FIGS. 41A and 41B are cutaway views of a proximal portion of thecatheter insertion device of FIG. 34.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to a toolfor assisting with the placement into a patient of a catheter or othertubular medical device. For example, catheters of various lengths aretypically placed into a body of a patient so as to establish access tothe patient's vasculature and enable the infusion of medicaments oraspiration of body fluids. The catheter insertion tool to be describedherein facilitates such catheter placement. Note that, while thediscussion below focuses on the placement of catheters of a particulartype and relatively short length, catheters of a variety of types,sizes, and lengths can be inserted via the present device, includingperipheral IV's intermediate or extended-dwell catheters, PICC's,central venous catheters, etc. In one embodiment, catheters having alength between about 2.5 inches and about 4.5 inches can be placed,though many other lengths are also possible. In another embodiment acatheter having a length of about 3.25 inches can be placed.

Reference is first made to FIGS. 1A-1B and 2A-2B, which depict variousdetails regarding a catheter insertion tool (“insertion tool”),generally depicted at 10, according to one embodiment. As shown, theinsertion tool 10 includes a housing 12 that in turn includes a tophousing portion 12A separably mated with a bottom housing portion 12B. Aneedle hub 14 supporting a hollow needle 16 is interposed between thehousing portions 12A and 12B. The needle 16 extends distally from theneedle hub 14 so as to extend through the body of the insertion tool 10and out a distal end of the housing 12. In another embodiment, theneedle is at least partially hollow while still enabling thefunctionality described herein.

A notch 18 is defined through the wall of the needle 16 proximate thedistal end thereof. The notch 18 enables flashback of blood to exit thelumen defined by the hollow needle 16 once access to the patient'svasculature is achieved during catheter insertion procedures. Thus,blood exiting the notch 18 can be viewed by a clinician to confirmproper needle placement in the vasculature, as will be explained furtherbelow.

The insertion tool 10 further includes a guidewire advancement assembly20 for advancing a guidewire 22 through the needle 16 and into thevasculature of the patient once access by the needle has been achieved.The guidewire 22 is pre-disposed within the lumen of the needle 16, witha proximal end of the guidewire positioned proximate the proximal end ofthe needle hub 14, as best seen in FIGS. 1B and 2A. The guidewireadvancement assembly 20 includes a guidewire lever 24 that selectivelyadvances the guidewire in a distal direction during use of the insertiontool 10 such that the distal portion of the guidewire extends beyond thedistal end of the needle 16. The guidewire lever 24 includes a lever tab26 that engages the proximal end of the guidewire 22 so to push theguidewire through the lumen of the needle 16.

The guidewire advancement assembly 20 further includes a slide 28 thatis slidably attached to the top housing portion 12A. Two tabs 24A of theguidewire lever 24 operably attach to the slide 28 so that selectivemovement by a user of the slide results in corresponding movement of thelever 24, and by extension, the guidewire 22. Engagement of the levertabs 24A to the slide 28 also maintains attachment of the slide to thehousing 12. Of course, other engagement schemes to translate user inputto guidewire movement could also be employed. Suitable tracks areincluded in the top housing portion 12A to enable sliding movement ofthe slide 28 and the lever 24, including a track 34 extending to thedistal end of the housing 12.

The slide 28 includes two arms 30 that wrap partially about rails 32defined by the housing 12. In particular, during initial distaladvancement of the slide 28, the arms 30 slide on a bottom housing rail32A, best seen in FIG. 5B. During further distal advancement of theslide 28, the arms 30 slide past the bottom housing rail 32A and on to atop housing rail 32B, best seen in FIGS. 2A and 3A. With the arms 30 ofthe slide 28 no longer engaged with the bottom housing rail 32A, the twohousing portions 12A and 12B are able to separate, as will be describedfurther below.

The guidewire lever 24 includes a locking arm 36 resiliently disposed soas to spring up and engage an extension 36A defined in the interior ofthe top housing portion 12A when the slide 28 has been fully sliddistally. This prevents inadvertent retraction of the guidewire 22 oncedistally extended, which could otherwise cause unintended severing of adistal portion of the guidewire by the distal tip of the needle 16during insertion procedures. Note that engagement of the locking arm 36with the extension 36A can provide tactile and/or audible feedback tothe user in one embodiment so as to indicate full distal extension ofthe guidewire 22.

The insertion tool 10 further includes a catheter advancement assembly40 for selectively advancing in a distal direction a catheter 42,pre-disposed in the housing 12, and including a catheter tube 44 and ahub 46 at a proximal end thereof. As seen in FIGS. 1A and 1B, thecatheter 42 is partially and initially pre-disposed within a volumedefined by the housing 12 such that the lumen of the catheter tube 44 isdisposed over the needle 16, which in turn is disposed over theguidewire 22, as mentioned.

In particular, the catheter advancement assembly 40 includes a handle 48that defines a base 48A and two arms 50 extending from the handle base.Each arm 50 defines a grip surface 50A, finger grabs 50B, and one of twoteeth 50C. The grip surfaces 50A and finger grabs 50B enable the handleto be grasped or contacted by a user in order to selectively advance thecatheter 42 in a distal direction during use of the insertion tool 10 toinsert the catheter into the body of the patient. The teeth 50C engagecorresponding raised surfaces on the hub 46 so as to removably connectthe handle 48 to the catheter 42.

Additional components are included in relation to the handle 48 of thecatheter advancement assembly 40. A plug, or valve 52, is interposedbetween the handle base 48A and the catheter hub 46 to prevent bloodspillage when the catheter is first introduced into the patientvasculature. A safety housing 54, including a needle safety component 56therein, is removably attached to the handle 48 between the arms 50.Specifically, protrusions 60 included on the inner surfaces of thehandle arms 50 engage with corresponding recesses 62 (FIG. 10A) definedin the safety housing 54 to removably secure the safety housing to thehandle 48. A cap 56 supports the needle safety component 56 and coversthe end of the safety housing 54. As shown in FIG. 1B, the needle 16initially extends through the aforementioned components in the order asshown in FIG. 2B. Further details regarding the operation of thesecomponents are given below.

Note that in one embodiment the outer diameters of the needle 16 and thecatheter tube 44 are lubricated with silicone or other suitablelubricant to enhance sliding of the catheter tube with respect to theneedle and for aiding in the insertion of the catheter into the body ofthe patient.

The insertion tool 10 further includes a support structure 70 forstabilizing the needle 16 proximate its point of exit from the housing12. In the present embodiment, the support structure 70 includes aninterface 72 of the top housing portion 12A and bottom housing 12B thatis shaped to closely match the round shape of the needle 16 and cathetertube 44. The interface 72 stabilizes the needle 16 so as to preventexcessive “play” in the needle, thus improving user accuracy wheninitially accessing the vasculature of the patient.

As best seen in FIG. 2A, the top housing 12A, the needle hub 14, and thebottom housing 12B include engagement features 68 to maintain attachmentof the proximal end of the housing 12 even when more distal portions ofthe housing are separated, discussed below. Note, however, that varioustypes, sizes, and numbers of engagement features can be employed toachieve this desired functionality.

FIGS. 3A-9 depict various stages of use of the insertion tool 10 inplacing the catheter 42 in the vasculature of a patient. For clarity,the various stages are depicted without actual insertion into a patientbeing shown. With the insertion tool 10 in the configuration shown inFIG. 1A, a user grasping the insertion tool 10 first guides the distalportion of the needle 16 through the skin at a suitable insertion siteand accesses a subcutaneous vessel. Confirmation of proper vessel accesshaving been achieved is evident via blood flash, i.e., the presence ofblood between the outer diameter of the needle 16 and the inner diameterof the catheter tube 44 due to blood passing out the notch 18 from thehollow interior of the needle. Note that in one embodiment, the presenceof blood in the safety housing 54, which in one embodiment is atranslucent housing, can serve as a secondary blood flash indicator dueto blood entering the housing from the needle 16 when the vessel isaccessed.

After needle access to the vessel is confirmed, the guidewireadvancement assembly 20 is actuated, wherein the slide 28 is advanced bythe finger of the user to distally advance the guidewire 22 (FIGS. 3Aand 3B), initially disposed within the hollow needle 16. Note that theguidewire is distally advanced by the lever 24, which is operablyattached to the slide 28. Note also that during distal advancement ofthe slide 28, the slide arms 30 thereof travel along the rails 32 oneither side of the housing 12: first the bottom housing rails 32A, thenthe top housing rails 32B.

Distal guidewire advancement continues until the slide 28 has beendistally slid its full travel length, resulting in a predeterminedlength of the guidewire 22 extending past the distal end of the needle16, as shown in FIGS. 4A and 4B. In one embodiment, further distaladvancement of the slide 28 is prevented by contact of the lever tab 26with a distal portion of the needle hub 14, as shown in FIG. 4B. FIGS.5A and 5B show that, upon full distal advancement of the slide 28, theslide arms 30 thereof are no longer engaged with the bottom housingrails 32A, but rather with only the top housing rails 32B. This in turnenables the housing portions 12A and 12B to separate, as seen furtherbelow.

As seen in FIGS. 5A and 5B, once the guidewire 22 has been fullyextended within the vessel of the patient (FIGS. 4A and 4B), thecatheter advancement assembly 40 is actuated, wherein the handle 48 isdistally advanced by the user to cause the catheter tube 44 to slideover distal portions of the needle 16 and guidewire 22 and into thepatient's vasculature via the insertion site. FIGS. 6A and 6B show that,as the catheter is advanced via the handle 48, the housing portions 12Aand 12B are easily separated so as to enable the catheter hub 46 to exitthe distal end of the housing 12 and for the catheter to be insertedinto the patient vasculature to a suitable degree.

Note that, as shown in FIGS. 7A and 7B, during removal of the catheterfrom within the housing 12 of the insertion tool 10, the catheter slidesdistally along the needle 16 until the distal needle tip is receivedinto the safety housing 54 and engaged with the needle safety component56. FIG. 8 shows that the insertion tool 10 can then be separated fromthe catheter 42, leaving the handle 48 still attached to the catheterhub 46. As mentioned, the handle 48 includes the valve 52 interposedbetween the catheter hub 46 and the handle 48. Upon removal of theneedle 16 and safety housing 54 from the catheter 42, the valve 52occludes the catheter lumen so as to prevent inadvertent blood spillagefrom the catheter hub 46. As shown in FIG. 9, the handle 48 be removedfrom engagement with the catheter hub 46 via pulling, twisting, etc., soas to disengage the teeth 50C of the handle from the hub. An extensionleg can be attached to the catheter hub and the catheter 42 dresseddown, per standard procedures. Then housing 12 and handle 48 of theinsertion tool 10 can be discarded.

FIGS. 10A-10C give further details regarding the safety housing 54, aswell as the needle safety component 56 and its interaction with theneedle 16 in isolating the distal end thereof. As shown, the safetyhousing 54 is configured to enable the needle 16 to pass therethroughduring use of the insertion tool 10, as has been described, exiting thehousing via the extension 74 on the distal end of the housing. The cap58 is placed into the proximal end of the safety housing 54 and isconfigured to support the needle safety component 56 such that he needle16 initially passes through the safety housing, the cap, and the needlesafety component. Note that the extension 74 of the safety housing 54 inthe present embodiment extends into the valve 52 so as to open the valveduring use of the insertion tool 10, which eliminates undesired frictionbetween the valve and the needle.

FIG. 10C shows that the needle safety component 56 includes a bent body,or binding element 80 through which the needle initially extends, and afriction element 82. As seen in FIG. 10A, when the needle 16 iswithdrawn from the catheter 42 (FIG. 8), the distal tip of the needle iswithdrawn proximally through the extension 74 and past the distalportion of the needle safety component such that the needle is no longerin contact therewith. This enables the friction element 82 to cause thebinding element 80 to cant slightly, thus binding the needle 16 in placeand preventing its further travel with respect to the safety housing 54and isolating the needle distal tip within the housing so as to preventinadvertent needle sticks. In the present embodiment the frictionelement 82 includes a suitably sized O-ring. Suitable O-rings can beacquired from Apple Rubber Products, Lancaster, N.Y., for instance. Notethat further details regarding the needle safety component, itsoperating principles, and similar devices are disclosed in U.S. Pat.Nos. 6,595,955, 6,796,962, 6,902,546, 7,179,244, 7,611,485, and7,618,395, each of which is incorporated herein by reference in itsentirety. Of course, other needle safety devices can be employed toisolate the distal end of the needle.

Reference is now made to FIGS. 11A-13B in describing a catheterinsertion tool 110 according to one embodiment. Note that in this andsucceeding embodiments, various features are similar to those alreadydescribed in connection with the above embodiment. As such, onlyselected aspects of each embodiment to follow will be described.

The insertion tool 110 includes a housing 112 defined by a top housingportion 112A and a bottom housing portion 112B that together partiallyenclose the catheter 42. A needle hub 114 supporting a distallyextending needle 116 is included for disposal within the housing 112 andpositioned such that the catheter tube 44 of the catheter 42 is disposedover the needle. Note that partial enclosure of the catheter by theinsertion tool in this and other embodiments enables a clinician tomanipulate the insertion tool with hands that are closer to the distalend of the needle than what would otherwise be possible.

FIGS. 13A and 13B give further details regarding the needle hub 114,which is attached to the top housing portion 112A. A needle holder 126,included on a distal end of the needle hub 114, receives the proximalend of the needle 116 therein. The needle 116 is secured within theneedle holder 126 via adhesive, welding, or other suitable manner.Extensions 128 are included on opposite sides of the needle holder 126and are configured to be slidably received within corresponding slots130 defined on the sides of the bottom housing portion 112B. Suchengagement enables the bottom housing portion 112B to slide distallywith respect to the top housing portion 112A.

A top rail 132 is included on the needle hub 114 and is configured toengage a corresponding slot 134 defined in the proximal portion of thetop housing portion 112A so as to secure the needle hub to the tophousing portion. A lock out arm 136 is also included with the needle hub114 and positioned to engage the back plate 124 when the bottom housingportion 112B is slid distally to extend the guidewire from the needle116, thus preventing its retraction. Note that the guidewire 122initially distally extends from the back plate 124 and through theneedle holder 126 and needle 116, as best seen in FIG. 11D.

A guidewire advancement assembly 120 is included to selectively advancea guidewire 122, initially disposed within the lumen of the needle,distally past the distal end of the needle 116. The guidewireadvancement assembly 120 includes the bottom housing portion 112B towhich the guidewire 122 is attached at a proximal back plate 124thereof. As will be seen, the bottom housing portion 112B is distallyslidable with respect to the top housing portion 112A to enableselective distal advancement of the guidewire 122.

The insertion tool 110 further includes a catheter advancement assembly140 for selectively advancing the catheter 42 over the needle 116. Theadvancement assembly 140 includes a handle 146 initially and slidablydisposed between the top and bottom housings 112A and 112B and removablyattached to the hub 46 of the catheter 42. As best seen in FIGS. 12A and12B, the handle 146 includes two arms 150 for allowing a user toselectively slide the handle in order to advance the catheter 42. Thehandle 146 further includes a recess 152 in which is placed a needlesafety component 156 for isolating the distal tip of the needle 116 whenthe needle is withdrawn from the catheter 42. Further details regardingthe needle safety component are disclosed in U.S. Pat. Nos. 6,595,955,6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, eachincorporated by reference above.

The insertion tool 110 further includes a support structure 170 forstabilizing the needle 116 proximate the distal end of the housing 112.The support structure 170 in the present embodiment includes two flaps172 that are hingedly connected to the distal portion of the bottomhousing portion 112B. When closed as seen in FIGS. 11D and 12A, theflaps 172 serve to stabilize the needle 116 to assist the user of theinsertion tool 110 in inserting the needle into the patient. When open(FIG. 14D), the flaps 172 provide an opening to enable the catheter hub46 to be removed from the distal end of the housing 112, as will bedetailed further below. Before the bottom housing portion 112B is slidwith respect to the top housing portion 112A, the flaps 172 are disposedin a track 174 defined by the top housing portion. Other types andconfigurations of support structures can also be employed. The insertiontool 110 further includes gripping surfaces 176 on either side of thehousing 112 to aid in use of the tool during catheter insertionprocedures, detailed below.

FIGS. 14A-14E depict various stages of use of the insertion tool 110 ininserting a catheter into a patient. With the insertion tool 110 in theconfiguration shown in FIG. 14A, vascular access is achieved with theneedle 116 via user insertion of the needle into the patient at aninsertion site. Confirmation of vessel access can be achieved via theobservation of blood flashback via a distal notch in the needle 116, asdescribed in the previous embodiment, or in other suitable ways.

Once the distal portion of the needle 116 is disposed within a vessel ofthe patient, the guidewire 122 is extended past the distal end of theneedle and into the vessel by distally advancing the bottom housingportion 112B. Such advancement is achieved in the present embodiment byplacing a user's fingers on the folded-up flaps 172 of the bottomhousing portion 112B and pushing the flaps distally, thus extending theguidewire 122. The guidewire 122 is advanced until fully extended. Thelock out arm 136 of the needle hub 114 then engages the back plate 124of the bottom housing portion 112B and prevents retraction of theguidewire 122.

At this stage, the handle 146 of the catheter advancement assembly 140is distally advanced, by a user grasping of one or both arms 150thereof, so as to distally advance the catheter 42 through the insertionsite and into the patient vasculature. This is shown in FIG. 14C,wherein the catheter tube 44 is shown distally advancing over the needle116 and the guidewire 122.

As shown in FIG. 14D, continued distal advancement of the catheter 42causes the catheter hub 146 to urge the flaps 172 to open, thusproviding a suitable opening through which the hub may pass from theinsertion tool housing 112. Note that the flaps 172 are shaped such thatcontact with the catheter hub 46 urges each flap to fold outward, asseen in FIG. 14D. Note also that the flaps 172 are no longer disposedwithin the track 174 due to full distal advancement of the guidewire 122via finger pressure applied to the flaps 172 as described above.

FIG. 14E shows that, with the flaps no longer engaged within the track174, the top housing portion 112A and bottom housing portion 112B areable to separate at the distal ends thereof such that the handle 146,still attached to the catheter hub 46, can separate from the housing112. Though not shown at this stage, the needle safety component 156disposed in the recess 152 of the handle 146 isolates the distal end ofthe needle 116. The handle 146 can then be manually removed from thecatheter hub 46 (FIG. 14F), and placement and dressing of the catheter42 can be completed. The insertion tool 110, including the needle 116isolated by the needle safety component 156 of the handle 146, can besafely discarded.

Reference is now made to FIGS. 15A-18 in describing a catheter insertiontool 210 according to one embodiment. The insertion tool 210 includes ahousing 212 defined by a top housing portion 212A and a bottom housingportion 212B that together partially enclose the catheter 42. A slidingneedle hub 214 supporting a distally extending hollow needle 216 isslidably attached to the housing 212. In particular, the needle hub 214includes tracks 214A that slidably engage corresponding rails 218defined on the top and bottom housing portions 212A, 212B in a mannerdescribed further below. As shown in FIG. 15A, the needle hub 214 ispositioned distally with respect to the housing 212 such that the needle216 extends through a needle channel 224 (FIG. 18) and out a holedefined in a distal end of the top housing portion 212A so that theneedle is positioned as shown in FIG. 15A.

As seen in FIG. 15A, the housing 212 of the insertion tool 210 enclosesa portion of the catheter 42. An integrated guidewire/dilator 220 isincluded and disposed within the lumen of the catheter tube 44, as shownin FIGS. 15B and 16. The guidewire/dilator 220 includes a distalguidewire portion 220A and a proximal dilator portion 220B. Soconfigured, the guidewire/dilator 220 can not only serve as a guidewirein directing the catheter tube 44 through the insertion site of thepatient into the accessed vessel, but can dilate the insertion site inadvance of catheter insertion therethrough. In other embodiment, noguidewire/dilator need be used. In one embodiment, it is appreciatedthat the guidewire/dilator 220 can proximally extend through the entirecatheter 42 and include on a proximal end thereof a luer cap connectableto a proximal luer connector of the catheter. Note also that FIG. 15Ashows a sterile bag 217 attached to the housing 212 so as to cover andisolate the proximal portion of the catheter 42. For clarity, the bag217 is included only in FIG. 15A, but could be included with insertiontools of varying configurations so as to protect and isolate portions ofthe catheter.

As seen in FIGS. 17A-17C, the needle 216 includes a longitudinallyextending needle slot 226 extending from a beginning point along thelength of the needle to the distal end thereof. FIG. 17B shows that theslot 226 can be optionally wider in a proximal portion thereof relativeto more distal slot portions. So configured, the needle slot 226 enablesthe guidewire/dilator 220 to be inserted into, slid relative to, andremoved from the needle 216 during operation of the insertion tool 210,described below. Note that the needle slot can extend the entire lengthof the needle, in one embodiment.

FIG. 18 shows the manner of entry of the guidewire/dilator 220 into theslot 226 of the needle 216 according to one embodiment, wherein theguidewire/dilator extends distally along a guide channel 222 defined inthe top housing portion 212A and into the hollow needle 216, which isdisposed in the needle channel 224, via the needle slot. (The guidechannel 222 is also seen in FIG. 15B.) In this way, theguidewire/dilator 220 can be distally slid through the hollow needle 216so as to extend beyond the distal needle end while still being able tobe removed from the needle via the slot 226 when the guidewire/dilatorand needle are separated from one another, as will be seen.

FIG. 18 also shows a support structure 270 for stabilizing the needle216, including an interface 272 defined by portions of the top housingportion 212A and the bottom housing portion 212B about the hole throughwhich the needle extends. Of course, other support structures can beemployed to provide stability to the needle to assist in inserting theneedle into the patient vasculature. FIG. 19 shows details of a lockout230 for the needle hub 214, included on the bottom housing portion 212B,for preventing further movement of the needle hub after it has beenretracted, as described below.

FIGS. 19-24 depict various stages of use of the insertion tool 210 ininserting a catheter into a patient. With the insertion tool 210 in theconfiguration shown in FIG. 19, vascular access is achieved with theneedle 216 via user insertion of the needle into the patient at aninsertion site.

Once the distal portion of the needle 116 is disposed within a vessel ofthe patient, the guidewire/dilator 220 is manually fed through thehollow needle 216 so as to extend past the distal end of the needle andinto the vessel. Such advancement is achieved in the present embodimentby distally moving the housing 212 and catheter 42 together whilekeeping the needle hub 214 stationary. The guidewire 122 is advanceddistally a suitable distance, which in the present embodiment, includesadvancement until a distal end of the housing 212 arrives at the skininsertion site.

FIGS. 20A and 20B show that after the guidewire/dilator 220 has beendistally extended into the vessel, the needle 216 is retracted from thevessel by proximally sliding the needle hub 214 along rail portions 218Adisposed on the top housing portion 212A. Proximal sliding of the needlehub 214 continues until the hub engages the rail portions 218B of thebottom housing portion 212B and is fully slid to the proximal end of thehousing 212, as shown in FIGS. 21A and 21B. The needle hub 214 engagesthe lock out 230 (FIG. 20B) so as to prevent future distal movement ofthe needle hub or needle 216. In this position, the needle 216 is fullyretracted into the insertion tool housing 212 such that the distal endof the needle is safely isolated from the user (FIG. 21B). Note that inone embodiment a needle safety component can be added to the insertiontool to further isolate the tip of the needle. Note that the distalportion of the guidewire/dilator 220 remains in the vessel of thepatient, having been able to separate from the needle 216 duringretraction thereof via the needle slot 226.

At this stage, the bottom housing portion 212B (FIG. 22) and the tophousing portion 212A (FIG. 23) are removed from the catheter 42. Thecatheter 42 can then be inserted through the insertion site and into thevessel of the patient. Note that the guidewire/dilator 220 is stilldisposed within the catheter tube 44 and that the dilator portionassists the distal end of the catheter tube to enter the vessel bygradually enlarging the insertion site and the vessel entry point.

As mentioned, in one embodiment, the proximal portion of the catheter42, including the hub 46 and connected extension leg, is covered by asterile bag, which is attached to the housing 212. The sterile bag canbe removed after the catheter is fully inserted into the patient vesselor can be removed when the housing portions 212A and 212B are removed.In FIG. 24, the guidewire/dilator 220 is then removed from the catheter42 and the catheter dressed and finalized for use. The guidewire/dilator220 and other portions of the insertion tool 210 are discarded.

FIGS. 25A and 25B depict details regarding a needle blunting system forisolating a distal end 316A of a hollow needle 316, according to oneembodiment. As shown, the needle distal end 316A includes a bevel thatis configured such that its cutting surfaces are disposed at an innerdiameter 318 of the needle 316. Thus, when a suitably sized guidewire320 is distally extended past the distal end 316A of the needle 316, thecutting surfaces of the needle are blocked by the proximity thereto ofthe guidewire, thus safely isolating the needle end from a user. Inaddition, blunting the distal end 316A of the needle 316 in this mannerprevent the needle end from damaging sensitive inner walls of the vesselafter the needle tip has been inserted herein. At this point, a distalend 44A of the catheter tube 44 can then be distally advanced over theneedle 316 and guidewire 320. FIG. 26 depicts a needle end bevel 316Aaccording to another embodiment, including an additional filletcomponent 319. Such a blunting system can be employed in one or more ofthe insertion tools described herein.

Reference is now made to FIG. 27 in describing a catheter insertion tool410 according to one embodiment. The insertion tool 410 includes ahousing 412 that partially encloses the catheter 42. A distallyextending hollow needle 416 is disposed with the housing 412 such thatthe needle extends out the distal end of the housing 412

A guidewire advancement assembly 420 is shown for selectively advancinga guidewire 422, including a slide 428 that slides along a track 430defined in the housing 412. The guidewire 422 is attached to the slide428 and extends proximally within the housing 412 until it bends,forming a guidewire bend 422A, toward the distal end of the housing andpasses into the hollow needle 416 via a proximal end 416A thereof forselective distal advancement past the distal end of the needle via useractuation of the slide. Distal advancement of the guidewire 422 out thedistal end of the needle 416 is stopped when the guidewire bend 422Aengages the needle proximal end 416A.

A catheter advancement assembly 440 is also shown for selectivelyadvancing the catheter tube 44 over the needle 416, including a slide448 that slides along the track 430, and a carriage 450 disposed withinthe housing 412 and operably connected to the slide 448. The carriage450 is initially engaged with the catheter hub 46 such that distalsliding of the slide 448 causes the catheter to be distally advancedtoward the distal housing end.

The insertion tool 410 further includes a support structure 470 forstabilizing the needle 416, including two doors 472 hingedly attachedvia pins to the distal end of the housing 412. The doors 472 serve tostabilize the needle 416 during insertion into the patient. Later, whenthe catheter tube 44 and catheter hub 46 are advanced distally by theslide 448, the doors 472 are opened, enabling the catheter 42 to passthrough the doors and be separated by the user from the insertion tool410. In the present embodiment, a wedge feature is included on thebottom surface of the slide 428, the wedge feature being configured topush the doors 472 open when the slide is slid distally, as describedherein. Such a wedge or other suitable feature can be included in otherembodiments described herein as well.

After separation from the insertion tool 410, the catheter 42 can thenbe advanced and placed as needed into the patient by the user. Notethat, though none is shown, a needle safety component can be includedfor isolating the distal tip of the needle 416. In one embodiment,distal sliding of the guidewire slide 428 can partially open the doors472 in preparation for catheter advancement.

FIG. 28 shows the insertion tool 410 including a support structure 480according to another embodiment, wherein two half-conically shaped doors482 are hingedly connected to the housing 412 (via living hinges orother suitable connective scheme) and configured to stabilize the needle416. The carriage of the insertion tool 410 in FIG. 28 is also longerrelative to that of FIG. 27. Thus, it is appreciated that variousdifferent support structures and configurations can be employed forstabilizing the needle at or near its exit point from the insertion toolhousing.

Reference is now made to FIGS. 29A and 29B in describing a catheterinsertion tool 510 according to one embodiment. The insertion tool 510includes a housing 512 that partially encloses the catheter 42. A hollowneedle 516 distally extends from a needle hub 514 that caps a proximalend of the housing 512 such that the needle extends out the distal endof the housing 512.

A guidewire advancement assembly 520 is shown for selectively advancinga guidewire 522, including a slide 528 that slides along a track 530defined in the housing 512. The guidewire 522 is attached to the slide528 and extends proximally within the housing 512 and out through apigtail 524, attached to the proximal end of the housing 512, via a topone of two holes 514A defined in the needle hub 514. Near the proximalend of the pigtail 524, the guidewire 522 bends to form a U-shapedguidewire bend 522A and distally extends back into the housing 512 topass into the hollow needle 516 via a bottom one of the two needle hubholes 514A, for eventual distal advancement out the distal end of theneedle when the slide 528 is selectively actuated by a user. Such distaladvancement of the guidewire 522 out the distal end of the needle 416 isstopped when the guidewire bend 522A abuts the holes 514A defined in theneedle hub 514.

A catheter advancement assembly 540 is also shown for selectivelyadvancing the catheter tube 44 over the needle 516, including a slide548 that slides along the track 530, and a carriage 550 disposed withinthe housing 512 and operably connected to the slide. The carriage 550can be initially engaged with the catheter hub 46 such that distalsliding of the slide 548 causes the catheter to be distally advancedtoward the distal housing end. In the present embodiment a bulge 522B isincluded on the guidewire 522 such that, when the guidewire is distallyadvanced by user actuation of the (guidewire advancement) slide 528, thebulge is advanced and engages an internal portion of the (catheteradvancement) slide 548. This in turn causes the slide 548 to be advancedas well, resulting in distal advancement of the catheter 42. Thus, thecatheter can be advanced directly via the slide 548, or indirectly viathe slide 528, in one embodiment.

The insertion tool 510 further includes a support structure 570 forstabilizing the needle 516, including a plug 572 that includes a plughole 574 defined therein through which the needle 516 extends. The plug572 is attached via the track 530 to the slide 528 and occludes thedistal end of the housing 512, thus serving to stabilize the needle 516that passes therethrough during needle insertion into the patient.Later, when the guidewire 522 is advanced distally by the slide 528, theplug 572 also distally advances out the housing 512, thus opening thehousing distal end and enabling the catheter 42 to pass therethrough.The catheter 42 can then be separated by the user from the insertiontool 510 and advanced into final position by the user. Note that, thoughnone is shown, a needle safety component can be included for isolatingthe distal tip of the needle 516. Note also that after the plug 572 isremoved from its initial position in the housing 512, the catheter tube44 and needle 516, no longer being constrained by the support structureplug hole 574, can axially relocate toward the center of the housing, inone embodiment. This holds true for the embodiments of FIGS. 30 and 31as well.

Reference is now made to FIG. 30 in describing a catheter insertion tool610 according to one embodiment. The insertion tool 610 includes ahousing 612 that partially encloses the catheter 42. A hollow needle 616distally extends from a needle hub 614 that caps a proximal end of thehousing 612 such that the needle extends out the distal end of thehousing 612. The needle 616 includes a longitudinally extending proximalslot 616A that extends from the proximal end of the needle 616 to adistal end 616B of the slot.

A guidewire advancement assembly 620 is shown for selectively advancinga guidewire 622, including a slide 628 that slides along a track 630defined in the housing 612. The guidewire 622 is attached to the slide628 and extends proximally within the housing 612 until it bends,forming a U-shaped guidewire bend 622A, toward the distal end of thehousing and passes into the hollow needle 616 via the proximal slot 616Athereof for selective distal advancement past the distal end of theneedle via user actuation of the slide. Note that distal advancement ofthe slide 628 causes the slide to separate from the housing 612 whilestill being attached to the guidewire 622. Distal advancement of theguidewire 622 out the distal end of the needle 616 is stopped when theguidewire bend 622A engages the distal end 616B of the proximal slot616A of the needle.

A catheter advancement assembly 640 is also shown for selectivelyadvancing the catheter tube 44 over the needle 616, including a carriage650 disposed within the housing 612 and operably connected to the slide628 such that actuation of the slide distally advances both theguidewire 622 and the carriage 650. The carriage 650 is not initiallyengaged with the catheter hub 46, but engages the hub after an amount ofdistal advancement. This in turn causes the catheter 42 to be distallyadvanced toward the distal housing end.

The insertion tool 610 further includes a support structure 670 forstabilizing the needle 616, including a plug 672 that includes a plughole 674 defined therein through which the needle 616 extends. The plug672 is attached via the track 630 to the slide 628 and occludes thedistal end of the housing 612, thus serving to stabilize the needle 616that passes therethrough during needle insertion into the patient.Later, when the guidewire 622 is advanced distally by the slide 628, theplug 672 also distally advances out the housing 612, thus opening thehousing distal end and enabling the catheter 42 to pass therethrough.The catheter 42 can then be separated by the user from the insertiontool 610 and advanced into final position by the user. Note that, in oneembodiment, the carriage 650 can include a needle safety component forisolating the distal end of the needle 616.

Reference is now made to FIG. 31 in describing a catheter insertion tool710 according to one embodiment. The insertion tool 710 includes ahousing 712 that partially encloses the catheter 42. A hollow needle 716distally extends from a needle hub 714 that caps a proximal end of thehousing 712 such that the needle extends out the distal end of thehousing 712.

An advancement assembly 720 is shown for selectively advancing aguidewire 722 and catheter 42. The advancement assembly 720 includes awheel 730, selectively rotatable by a user, that is attached via afilament 726 or other suitable component to a carriage 750. Theguidewire 722 is attached to the carriage 750 and extends proximallywithin the housing 712 and out through a pigtail 724, attached to theproximal end of the housing 712, via a one of two holes defined in theneedle hub 514 (similar to the holes 514A in the needle hub 514 of FIGS.29A, 29B). Near the proximal end of the pigtail 724, the guidewire 722bends to form a U-shaped guidewire bend 722A and distally extends backinto the housing 712 to pass into the hollow needle 716 via the other ofthe two holes defined in the needle hub 714 for eventual distaladvancement out the distal end of the needle when the wheel 730 isselectively actuated by a user. Such distal advancement of the guidewire722 out the distal end of the needle 716 is stopped when the guidewirebend 722A abuts the above-mentioned holes defined in the needle hub 714.

The advancement assembly 720 selectively advances the catheter tube 44over the needle 716 and includes the aforementioned carriage 750disposed within the housing 712 and operably connected to the wheel 730via the filament 726 such that rotation of the wheel distally advancesthe carriage 750. The guidewire 722, a proximal end of which beingattached to the carriage 750, is also advanced distally through theneedle, as described above. Note that in one embodiment the wheel 730,by virtue of the non-rigid filament 726 connecting the wheel to thecarriage 750, ensures that the guidewire 722 is only distally advanced,and not proximally retractable.

Distal advancement of the carriage 750 causes the carriage—which is notinitially engaged with the catheter hub 46—to engage the hub after anamount of distal advancement. This in turn causes the catheter 42 to bedistally advanced toward the distal housing end.

The insertion tool 710 further includes a support structure 770 forstabilizing the needle 716, including a door 772 hingedly attached tothe distal end of the housing 712 and including a hole 774 therein forenabling passage of the needle 716 therethrough. The door 772 serves tostabilize the needle 716 during insertion into the patient. Later, whenthe catheter tube 44 and catheter hub 46 are advanced distally by thewheel 730 and the carriage 750, the door 772 is pushed open by the hub,enabling the catheter 42 to be separated by the user from the insertiontool 710. The catheter 42 can then be advanced for final placementwithin the patient by the user. Note that, though none is shown, aneedle safety component can be included for isolating the distal tip ofthe needle 716.

Reference is now made to FIGS. 32A-32I in describing a catheterinsertion tool 810 according to one embodiment. The insertion tool 810includes a housing 812 that at least partially encloses the catheter 42.A hollow needle 816 distally extends from a needle hub 814 includedwithin the housing 812 such that the needle initially extends out thedistal end of the housing 812. The needle 816 includes a distal slot816A, similar to the previously described needle slot 226 (FIGS.17A-17C), for enabling a guidewire/dilator 822, similar to thepreviously described guidewire/dilator 220 (FIG. 16) to be removablyinserted therein. The catheter 42 is disposed over the guidewire/dilator822.

The needle hub 814 further includes a needle retraction system 818 forselectively retracting the needle 816 into the housing 812 so as toisolate the distal tip of the needle from the user in a safe manner. Theretraction system 818 includes a spring 819 or other suitable retractiondevice operably coupled to the needle 816 for effecting the needleretraction.

An advancement assembly 820 is shown for selectively advancing theguidewire/dilator 822 as well as the catheter 42. The advancementassembly 820 includes a slide 828 that travels in a track 830 defined inthe housing 812. The slide 828 is operably attached to a ratchet bar 824slidably disposed within the housing 812. The ratchet bar 824 includes aplurality of upper teeth 826 for selective catheter advancement, and atleast one lower tooth 826A for actuating a retraction trigger 880 of theneedle retraction system 818, as will be described. The hub 46 of thecatheter 42 disposed within the housing 812 has removably attachedthereto a cap 834 including a prong 836 for engaging the upper teeth 826of the ratchet bar 824.

The insertion tool 810 further includes a support structure 870 forstabilizing the needle 816, including a housing hole 872 defined by thedistal end of the housing 812. The housing hole 872 is sized to providestability to the needle 816 at its point of exit from the housing.

FIGS. 32A-32I depict various stages of use of the insertion tool 810 ininserting a catheter into a patient. With the insertion tool 810 in theconfiguration shown in FIG. 32A, vascular access is achieved with theneedle 816 via user insertion of the needle into the patient at aninsertion site. Blood flashback can be observed via the distal slot 816Aof the needle 816 to confirm proper positioning of the distal end of theneedle within the patient's vessel. As shown in FIG. 32B, the slide 828is slid distally to advance the guidewire/dilator 822, a distal portionof which is pre-disposed within the needle 816 via the distal slot 816A,distally out the distal end of the needle and into the vessel of thepatient. As shown, the guidewire/dilator 822 is advanced indirectly bythe ratchet bar 824, which is moved by the slide 828. In particular, aproximate one of the upper teeth 826 of the ratchet bar 824 engages theprong 836 of the cap 834 fitted over the catheter hub 46. Thus, when theslide 828 and ratchet bar 824 are moved distally, the catheter 42 andguidewire/dilator 822 disposed therein are also moved distally, as shownin FIG. 32B. Similar ratcheting movement occurs in the successive stepsas well.

Sliding of the slide 828 in the stage shown in FIG. 32B also causes thebottom tooth 826A of the ratchet bar 824 to engage the retractiontrigger 880 of the needle retraction system 818. This in turn enablesthe spring 819 to expand and retract the needle 816 and retractionsystem 818 into the housing 812 such that the distal tip of the needleis isolated from the user within the housing.

FIG. 32C shows the return of the slide 828 to its initial position,which causes the ratchet bar 824 to also return to its initial position.Because the prong 836 of the cap 834 attached to the catheter hub 46 isdistally angled, however, the teeth 826 of the ratchet bar slide pastwithout retracting the catheter 42 such that the catheter remains inposition.

In FIG. 32D, the slide 828 is again distally advanced, which causes aproximate upper tooth 826 of the ratchet bar 824 to engage the cap prong836 and further advance the guidewire/dilator 822 distally into thevessel. As it is disposed over the guidewire/dilator 822, the catheter42 at this or a successive stage is also advanced into the vessel,depending on catheter length, distance to insertion site, etc. The slide828 is subsequently retracted to its initial position, as shown in FIG.32E. Note that ratchet retraction can be user activated or automaticallyactivated by a suitable system included in the insertion tool 810.

In FIG. 32F, the slide 828 and ratchet bar 824 are again distallyadvanced, resulting in further distal advancement out of the housing 812of the guidewire/dilator 822 and catheter 42. The slide 828 issubsequently retracted to its initial position, as shown in FIG. 32G. InFIG. 32H, the slide 828 and ratchet bar 824 are distally advanced afinal time, resulting in near-complete distal advancement of theguidewire/dilator 822 and attached catheter 42 from the housing 812 ofthe insertion tool 810. At this stage, the hub 46 of the catheter 42 canbe grasped and the catheter removed from the insertion tool 810, whichcan then be discarded. Final positioning of the catheter 43 within thevessel can then be manually performed by the user. The cap 834 is alsoremoved from the catheter hub 46.

FIGS. 33A-33C depict details of a needle safety component for isolatingthe distal end 16A of the needle 16, the needle including the distalnotch 18 as discussed above in connection with FIGS. 1A-10C, accordingto one embodiment. As shown, a safety housing 954 including a hingeddoor is included so as to ride over the needle 16. Two needle safetycomponents 956 are oppositely disposed within the safety housing 954 andeach also rides over the needle 16. Each needle safety componentincludes a base 958 defining a hole through which the needle 16 passesand a plurality of arms 960. The arms 960 extend from the base 958 andconverge toward one another in conical fashion such that an end of eacharm abuts the needle surface. The arms 960 are configured to engage thenotch 18 defined in the distal portion of the needle 16 and preventfurther movement of the needle 16 with respect to the needle safetycomponent 956. In particular, each arm 960 compressively engages theouter surface of the needle 16 such that when one of the arms encountersthe needle notch 18, the arm will descend into the notch slightly so asto lock the needle 16 in place with respect to the needle safetycomponent 956. Two needle safety components 956 are disposed in thesafety housing 954 so as to prevent further needle movement in eitherdirection, distally or proximally. Thus, the distal end 16A of theneedle 16 is safely isolated within the safety housing 954, as seen inFIGS. 33A-33C. Note that the needle safety component described here isuseful for isolating a needle even when the guidewire 22 still extendstherethrough, as seen in FIG. 33C, for example.

In other embodiments, only one needle safety component as describedabove may be used. Thus, the needle safety component described hereserves as one example of a variety of needle safety components that maybe employed in connection with the present disclosure.

It is appreciated that in one embodiment the insertion tool can includea sterile sheath or bag that is disposed over a distal portion of thecatheter that distally extends from the insertion tool housing so as toisolate the catheter. The needle, pre-disposed within the catheter andretractable into the insertion tool housing, can extend from the bag togain vascular access. Thereafter, the bag can be compressed toward thehousing as the catheter is advanced into the vasculature, then disposedof once the catheter is fully inserted. In one embodiment, the bag caninclude a grip wing or other device that helps to grasp the catheter orneedle through the bag during insertion. Further note that the insertiontools described herein can include a cap or other protective device thatis removably attached to the insertion tool before use so as to preservethe sterility of the needle and catheter.

Reference is now made to FIG. 34, which depicts an exploded view of thecatheter insertion device 10 according to one embodiment, includingcomponents similar to those that have already been described above. Assuch, only selected differences are discussed below.

FIG. 34 shows that in the present embodiment the guidewire 22 is loopedback on itself to substantially define a U-shaped configuration. FIGS.36A and 36B shows the manner in which the guidewire 22 is disposedwithin the housing 12 of the catheter insertion device 10. Inparticular, these figures show that a proximal end of the guidewire 22is anchored to a portion of the device 10, namely, at an anchor point982 on the top portion 12A of the housing 12. FIG. 37 shows that theguidewire 22 extends proximally and removably within a guide channel 984defined on an interior surface of the top housing portion 12A. FIGS. 36Aand 36B show that an intermediate portion of the guidewire 22 loops backon itself proximate the proximal end of the device 10. Guide surfaces980 (FIG. 35) disposed near the proximal end of the guidewire lever 24constrain the flexible guidewire 22 into the looped, substantiallyU-shaped configuration. The looped-back intermediate portion of theguidewire 22 then extends toward the distal end of the device 10 along achannel 986, best seen in FIG. 38, defined on an interior surface of thebottom housing portion 12B of the housing 12 before it passes into thehollow needle 16. The free distal end of the guidewire 22 initiallyresides within the needle 16.

So disposed as described immediately above, the guidewire 22 ispositioned for selective advancement by the guidewire advancementassembly 20 such that the free distal end thereof can distally extendfrom the open distal tip of the needle 16. This selective advancement ofthe guidewire 22 is achieved in the present embodiment via distalmovement of the guidewire advancement slide 28 included on the devicehousing 12. Distal movement of the guidewire advancement slide 28 causescorresponding distal sliding movement of the guidewire lever 24. Theguide surfaces 980 of the guidewire lever 24 push the bend of theguidewire 22 distally as the lever advances. Note that the guidewire 22is sufficiently rigid so as to be advanced by the guidewire lever 24without buckling. Also, the guide surfaces 980 and guidewire 22 areconfigured to enable retraction of the guidewire 22 back into theinsertion tool housing 12 when the guidewire advancement slide 28 orother suitable mechanism is slid proximally.

This pushing movement of the slidable guidewire lever 24 causes thedistal end of the guidewire 22 to extend distally from the open distaltip of the needle 16. Because of its anchored proximal end at anchorpoint 982 and its bent or looped U-shape configuration, the guidewire 22is distally advanced at a rate of about twice the rate of sliding of theguidewire advancement slide 28 and about twice the rate of guidewireadvancement in the device configuration of FIGS. 1A-9, which results inabout twice the length of guidewire extension when compared with thelength of movement of the guidewire advancement slide 28. This furtherdesirably results in a relatively longer length of guidewire extensioninto the vein or other patient vessel so as to more suitably guide thecatheter 42 into the patient's body. As such, the guidewire andadvancement assembly described here operates as a type of “reversepulley” system for distal guidewire advancement. Note that other loopingconfigurations of the guidewire can be included with the device 10 inaddition to those shown and described herein. Also, differing ratios ofguidewire extension vs. advancement assembly movement are also possiblein other embodiments.

Note that the looping conduit and guidewire advancement handle are onlyexamples of structures that can suitably perform the desiredfunctionality described herein. Indeed, other structures can be employedto accomplish the principles described in connection with the presentembodiment. Also, though shown and described above to be attached to thecatheter insertion device housing, the proximal end of the guidewire canbe attached to other structures within/on the device, such as the needlehub 14, for instance. The majority length of the guidewire in oneembodiment includes a metal alloy of nickel and titanium commonlyreferred to as nitinol, which is sufficiently rigid and can be disposedin the U-shaped configuration without retaining a memory of thatposition when the guidewire is advanced. Note that other suitableguidewire materials can also be employed.

FIGS. 39A and 39B depict various details regarding the binding element80, described further above, of the needle safety component 56 forshielding the distal tip of the needle 16 once catheter insertion iscomplete. As shown, the binding element 80 (which is also referred toherein as a binding member) includes a front plate 992 defining a hole992A, and a forked back plate 994. A protuberance 996 extends from oneof the forks of the back plate 994. A horseshoe-shaped needlepass-through element 998 is also included in a spaced-apart arrangementfrom the front plate 992 and defines a hole 998A in coaxial alignmentwith the hole 992A of the front plate.

A friction element 1000, also referred to herein as a friction member,is also included with the binding element 80 in the present embodiment,namely, an annular elastomeric element, or O-ring 1002, as seen in FIGS.40A and 40B. As shown, the O-ring 1002 is configured to wrap around botha portion of the needle 16 and the forked back plate 994. Theprotuberance 996 is employed to aid in maintaining the O-ring 1002 inplace as shown in FIGS. 40A and 40B. With the O-ring 1002 so positioned,a relatively constant urging force is imparted by the O-ring to thebinding element 80, for use in shielding the distal tip of the needle16, as will be described further below. Note that the elastomericelement can take forms other than an O-ring while performing the samefunctionality. For instance, a rod or length of elastomeric materialthat is wrapped about a portion of the binding element and the needlecould also be employed.

FIGS. 40C and 40D show the binding element 80 disposed in the carriage1008, which is in turn disposed within the safety housing 54. As shown,the carriage 1008 defines two constraining surfaces 1010 against whichcorresponding portions of the front plate 992 of the binding elementinitially rest when the needle 16 initially extends through the carriageand the binding element. A retaining ring 1008A through which the needle16 slidably passes enables engagement of the needle with the carriage1008.

The binding element 80 is initially slidably disposed with the needle 16in the state shown in 40A-40D (showing the binding element before it hasshielded the distal tip of the needle) such that relative slidingmovement between the needle and the binding element is permitted.Passage of the needle 16 through the hole 998A of the needlepass-through element 998 initially limits canting movement of thebinding element 80.

The needle 16 also passes through the hole 992A of the front plate 992such that the needle is straddled by the forks of the forked back plate994. As mentioned, the O-ring 1002 is disposed about the needle 16 andthe back plate 994 so as to provide a drag force when the carriage 1008and binding element 80 (both housed within the safety housing 54 (FIG.34) are slid distally along the length of the needle 16 during use ofthe device 10. The drag force provided by the O-ring 1002 during suchdistal sliding in turn imparts a rotational moment on the bindingelement 80 (by virtue of forces provided via the contact of the bindingelement with the O-ring) to urge the binding element to rotate in aclockwise motion, from the perspective of the drawing shown in FIG. 40C.

Such clockwise rotation of the binding element 80 is prevented by theneedle pass-through feature 998 while the needle 16 extends through thebinding element. Once the safety housing 54 containing the carriage 1008and binding element 80 has been slid distally a sufficient distance suchthat the needle pass-through element 998 slides past and off the distalend of the needle 16, however, the binding element is no longerconstrained and the drag force imparted by the O-ring 1002 causes thebinding element to cant clockwise with respect to the needle, from theperspective of the drawing shown in FIG. 40C. This canting locksmovement of the binding element 80 and, by extension, the carriage 1008,with respect to the needle 16, by virtue of physical binding between theouter surface of the needle 16 with the perimeter of the front platehole 992A, which thus acts as a binding surface. With the distal tip ofthe needle 16 safely disposed within the locked carriage 1008, the useris thus protected from an accidental needle stick.

As mentioned above, the O-ring 1002 imparts a relatively constant urgingforce for canting the binding element 80, which keeps the bindingelement canted (after withdrawal of the needle distal tip into thecarriage as described above) so as to more securely lock the carriage1008 over the distal tip of the needle 16. This constant urging force isbeneficial, for example, in instances when the needle 16 is pushed backand forth with respect to safety housing 54/carriage 1008 after it hasbeen locked over the needle distal tip to ensure that the bindingelement does not return to an orientation in which the needlepass-through feature 998 can re-engage the needle 16 and unlock theneedle safety component 56. Note that the O-ring 1002 can be employedwith needles and binding elements larger or smaller than those shown anddescribed herein.

The O-ring 1002 in the above embodiments is sufficiently compliant so asto stretch over the aforementioned structures while imparting thedesired force, as explained above. In one embodiment, the O-ring 1002material includes any one or more of natural or synthetic rubber,elastomers, polymers, thermoplastics, silicones, etc. In one embodiment,the O-ring material is selected so as to provide sufficient tearresistance, ability to impart the desired friction, and chemicalcompatibility. The size of the O-ring can vary according to the size andconfiguration of the binding element and needle. In other embodiments,the O-ring can include other shapes, materials, and positionalplacements while still providing the intended functionality.

FIG. 41A shows that the guidewire lever 24 can include a catheteradvancement feature that enables the guidewire lever to distally advancethe catheter 42 in addition to advancing the guidewire 22 as describedabove. In the present embodiment, the catheter advancement featureincludes an advancement tab 1014 disposed on the proximal portion 24A ofthe guidewire lever 24 and disposed so as to physically engage the cap58 of the safety housing 54 when the guidewire lever 24 is moveddistally via distal sliding by the user of the slide 28 (FIG. 34). Suchengagement is shown in FIG. 41B. Further distal movement of theguidewire lever 24 results in distal advancement of the safety can 54and the catheter 42 indirectly but operably attached thereto (FIG. 34).The slide 28 in the present embodiment can be slid to distally advancethe catheter 42 a predetermined distance via the advancement tab 1014 ofthe guidewire lever 24. In one embodiment, the predetermined distanceadvances the catheter 42 until its distal end distally advances over thedistal tip of the needle 16. Further distal advancement of the catheter42 can be achieved via distal sliding of the handle 48 as needed (FIG.34). In another embodiment, the slide 28 is configured to distallyadvance the catheter the full distal distance needed, via theadvancement tab 1014.

The position of the advancement tab 1014 of FIG. 41A is such so as toprovide staged advancement of the guidewire 22 and catheter 42. Inparticular, distal advancement of the guidewire lever 24 from theposition shown in FIG. 41A produces immediate advancement of theguidewire 22 while the safety housing 54 and catheter 42 remain inplace. Further distal advancement of the guidewire lever 24 to theposition shown in FIG. 41B causes the advancement tab 1014 to engage anddistally advance the safety can 54 and catheter 42, as described above,while continuing to distally advance the guidewire 22.

Thus, in addition to distally advancing the guidewire 22 out through theneedle 16, the guidewire lever 24 can also advance the catheter 42distally along the needle 16 and into a vessel of the patient, asdescribed further above. Note that the particular shape andconfiguration of the advancement tab 1014, together with its manner ofengagement with, and magnitude of travel imparted to, the safety housingand/or catheter can vary from what is shown and described herein.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method for inserting a catheter into a body ofa patient using a catheter insertion tool, the insertion tool includinga housing in which at least a portion of the catheter is initiallydisposed, a hollow needle distally extending from the housing, aguidewire initially pre-disposed within the needle, the methodcomprising: inserting the needle extending from the insertion tool intothe patient; moving an advancement assembly of the insertion tool afirst distance to correspondingly advance a distal end of the guidewireout of the needle a second distance greater than the first distance; andadvancing the catheter over the guidewire.
 2. The method for insertingaccording to claim 1, wherein advancing the catheter is at leastpartially performed via movement of the advancement assembly.
 3. Themethod for inserting according to claim 2, wherein the advancementassembly distally advances the guidewire before advancing the catheter.4. The method for inserting according to claim 3, wherein at least anintermediate portion of the guidewire is initially disposed within thehousing in a U-shaped configuration.
 5. The method for insertingaccording to claim 1, wherein the second distance is two times the firstdistance.
 6. A method for inserting a catheter into a patient,comprising: obtaining a catheter insertion tool, comprising: a housing;a needle extending from a distal end of the housing; a catheter disposedover the needle; a guidewire having a distal end disposed in the needle,an intermediate portion defining a U shaped bend, and a proximal enddistal of the intermediate portion; and a guidewire advancement assemblydesigned to selectively advance the distal end of the guidewire out of adistal opening of the needle; inserting the needle into the patient;moving the guidewire advancement assembly to advance the distal end ofthe guidewire out of the distal opening of the needle, wherein movementof the guidewire advancement assembly a first distance correspondinglymoves the distal end of the guidewire a second distance greater than thefirst distance; and advancing the catheter over the distal end of theguidewire.
 7. The method for inserting according to claim 6, wherein theproximal end of the guidewire is secured to an interior portion of thehousing, wherein the proximal end of the guidewire does not move duringthe moving step.
 8. The method for inserting according to claim 7,wherein the catheter insertion tool further comprises a track defined inthe housing designed to constrain a proximal portion of the guidewireduring the moving step.
 9. The method for inserting according to claim6, wherein the guidewire advancement assembly includes a guidewire leverdesigned to guide the intermediate portion of the guidewire, the movingstep including moving a slide coupled to the guidewire lever.
 10. Themethod for inserting according to claim 9, wherein the housing includesa top housing portion and a bottom housing portion separable from thetop housing portion, the slide engaged with the top housing portion andthe bottom housing portion to prevent separation of the top housingportion and the bottom housing portion until the slide is moved to afully distal position.
 11. The method for inserting according to claim10, wherein the catheter insertion tool further comprises a catheteradvancement assembly, the step of advancing the catheter includingmoving the catheter advancement assembly relative to the housing. 12.The method for inserting according to claim 11, wherein the catheteradvancement assembly comprises a handle including opposing armsextending between the top housing portion and the bottom housingportion, the step of advancing the catheter including moving the handleout of the housing after the slide is moved to the fully distalposition.
 13. The method for inserting according to claim 12, furthercomprising detaching the catheter advancement assembly from thecatheter.
 14. The method for inserting according to claim 6, wherein thecatheter insertion tool further comprises a catheter advancementassembly, the step of advancing the catheter including moving thecatheter advancement assembly relative to the housing.
 15. The methodfor inserting according to claim 14, wherein the catheter advancementassembly comprises a handle including opposing arms extending generallyperpendicular to the catheter, the step of advancing the catheterincluding moving the handle relative to the housing.
 16. The method forinserting according to claim 15, wherein the catheter advancementassembly further comprises a needle safety component, the method forinserting further comprising capturing a tip of the needle within theneedle safety component.
 17. The method for inserting according to claim16, wherein the needle safety component includes at least one bindingelement and at least one friction element, the capturing step includingthe at least one friction element causing the at least one bindingelement to cant and engage the needle after the tip of the needle entersinto the needle safety component.
 18. The method for inserting accordingto claim 16, further comprising detaching the catheter advancementassembly from the catheter after advancing the step of capturing theneedle.